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Pharmacovigilance Book B.Pharm 8th Semester

Click below to Buy E-Book Edition:
Buy Thakur Publication’s Pharmacovigilance book for B.Pharm 8th Sem as per Latest Syllabus of PCI. Pharmacovigilance textbook covered all important topics. This is the best book for Pharmacovigilance.
The Pharmacovigilance book is a comprehensive guide to the principles and practices of drug safety monitoring.
EXPRESS SHIPPING · REVISED EDITION · EXAM-ORIENTED
It covers topics such as adverse drug reactions, signal detection, risk management, regulatory requirements, and pharmacovigilance systems. The book provides practical knowledge and skills for pharmacovigilance professionals to ensure the safety of medicines in use.
AUTHORS- Dr. Agnimitra Dinda, Monika Saxena
ISBN- 978-93-90972-83-8
Tax excluded
Click below to Buy E-Book Edition:
Buy Thakur Publication’s Pharmacovigilance book for B.Pharm 8th Sem as per Latest Syllabus of PCI. Pharmacovigilance textbook covered all important topics. This is the best book for Pharmacovigilance.
The Pharmacovigilance book is a comprehensive guide to the principles and practices of drug safety monitoring.
EXPRESS SHIPPING · REVISED EDITION · EXAM-ORIENTED
It covers topics such as adverse drug reactions, signal detection, risk management, regulatory requirements, and pharmacovigilance systems. The book provides practical knowledge and skills for pharmacovigilance professionals to ensure the safety of medicines in use.
AUTHORS- Dr. Agnimitra Dinda, Monika Saxena
ISBN- 978-93-90972-83-8
Syllabus
Pharmacovigilance
(Course Code: BP805ET)
Module 01 10 Hours
Introduction to Pharmacovigilance
· History and development of Pharmacovigilance.
· Importance of safety monitoring of Medicine.
· WHO international drug monitoring programme.
· Pharmacovigilance Program of India(PvPI).
Introduction to Adverse Drug Reactions
· Definitions and classification of ADRs.
· Detection and reporting.
· Methods in Causality assessment.
· Severity and seriousness assessment.
· Predictability and preventability assessment.
· Management of adverse drug reactions
Basic Terminologies Used In Pharmacovigilance
· Terminologies of adverse medication related events.
· Regulatory terminologies.
Module 02 10 Hours
Drug and Disease Classification
· Anatomical, therapeutic and chemical classification of drugs.
· International classification of diseases.
· Daily-defined doses.
· International Non proprietary Names for drugs.
Drug Dictionaries and Coding In Pharmacovigilance
· WHO adverse reaction terminologies.
· MedDRA and Standardised MedDRA queries.
· WHO drug dictionary.
· Eudravigilance medicinal product dictionary.
· Information resources in pharmacovigilance
· Basic drug information resources.
· Specialised resources for ADRs.
Establishing Pharmacovigilance Programme
· Establishing in a hospital.
· Establishment & operation of drug safety department in industry.
· Contract Research Organisations (CROs).
· Establishing a national programme.
Module 03 10 Hours
Vaccine Safety Surveillance
· Vaccine Pharmacovigilance.
· Vaccination failure.
· Adverse events following immunization.
Pharmacovigilance Methods
· Passive surveillance – Spontaneous reports and case series.
· Stimulated reporting.
· Active surveillance – Sentinel sites, drug event monitoring and registries.
· Comparative observational studies – Cross sectional study, case control study and cohort study.
· Targeted clinical investigations.
Communication in Pharmacovigilance
· Effective communication in Pharmacovigilance.
· Communication in Drug Safety Crisis management.
· Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media.
Module 04 08 Hours
Safety Data Generation
· Pre clinical phase.
· Clinical phase.
· Post approval phase (PMS).
ICH Guidelines for Pharmacovigilance
· Organization and objectives of ICH.
· Expedited reporting.
· Individual case safety reports.
· Periodic safety update reports.
· Post approval expedited reporting.
· Pharmacovigilance planning.
· Good clinical practice in pharmacovigilance studies.
Module 05 07 Hours
Pharmacogenomics of adverse drug reactions
· Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
· Paediatrics
· Pregnancy and lactation
· Geriatrics
CIOMS
· CIOMS Working Groups
· CIOMS Form
CDSCO (India) and Pharmacovigilance
· D&C Act and Schedule Y.
· Differences in Indian and global pharmacovigilance requirements.